BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    n.a.

    DI: 04048551006269 · Model: 11581A · Karl Storz GmbH & Co. KG
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    n.a.
    Primary DI
    04048551006269
    Version / Model
    11581A
    Company Name
    Karl Storz GmbH & Co. KG
    Labeler DUNS
    315731430
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    21abe219-cb4e-444d-a769-9ba0abf3628b

    Device Description

    Miniature Straight Forward Telescope 0°

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    ["Liquid Chemical", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]

    Product Codes

    Code Name
    GCJ Laparoscope, general & plastic surgery

    GMDN Terms

    Code Name
    58936 Sialendoscope

    Identifiers

    Type ID
    Primary 04048551006269

    Premarket Submissions

    Submission Number Supplement Number
    K012527 000